MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on: (b)(6) 2006: patient presented with the following pre-op diagnosis: l4-5, l5-s1 spinal stenosis.Lumbar degenerative disk disease l4-5 , l5-s1.Low back pain.Bilateral leg radiculopathy.Multiple medical problems including diabetes.Procedures: complete decompression at l4-5, l5-s1 with total laminotomies, removal of lateral mass l4-5 and l5-s1.Left transforaminal lumbar interbody fusion at l4-5, l5-s1.Segmental pedicle screw instrumentation l4-5, l5-s1.Posterolateral lumbar fusion l4 to s1.Anterior interbody cage placement at l4-5 and l5-s1.Bone graft using local autograft and bmp.Neurologic monitoring.As per op notes: ¿¿¿ once again, surgeon sized and placed a 7 mm x 36 mm interbody cage in the same fashion that had at the l5-s1 level, which was place a bmp sponge anteriorly with some local autograft, place the cage, and then impact it anteriorly, and then pack more bmp and local autograft behind it¿¿¿¿.The patient was awakened in the operating room and taken to the post- anesthesia care unit in the good condition.On (b)(6) 2014: patient presented with the following pre-op diagnosis: lumbar stenosis, l3-4.Post-laminectomy syndrome with ectopic bone compromising the thecal sac nerve roots.Lumbar instrumentation compromising the nerve roots.Procedures: bilateral l3-4 re-entry laminotomies, medial facetectomies, and foraminotomies.Removal of bilateral l4-5, s1 pedicle screw instrumentation.Reentry laminotomies, medial facetectomies, foraminotomies, with removal of extensive ectopic bone.Removal of a large portion of back wall of the left l5 vertebra that most likely represented ectopic bone emanating out of the vertebral body requiring a limited partial vertebrectomy.Exploration of bilateral l4-5 fusion.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5633355
• MDR Text Key: 44448633
• Report Number: 1030489-2016-01329
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Device Lot Number: M115004AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention